ECMO ABI Detection With Hyperfine

Children's Mercy Hospital Kansas City

Status

Enrolling

Conditions

Extracorporeal Membrane Oxygenation Complication

Acute Brain Injury

Stroke, Acute

Hypoxia-Ischemia, Brain

Treatments

Device: Hyperfine

Study type

Interventional

Funder types

Other

Identifiers

NCT06469801

STUDY00003208

Details and patient eligibility

About

The primary objective is to characterize the prevalence and type of ABI following cannulation for pediatric patients who require ECMO support. The secondary objective is to describe the time course and rates of ABI using ultralow-field bedside MRI relative to both duration of ECMO support and clinical imaging obtained in routine care of pediatric ECMO patients.

Full description

Extracorporeal membrane oxygenation (ECMO) is frequently used to treat refractory cardiovascular and/or respiratory failure. As the support modality has evolved, survival has significantly improved, yet there are high rates of acute brain injury (ABI) in this population due to disease, patient, and treatment factors. This results in significant morbidity and mortality. Specifically, thromboembolic, hypoxic-ischemic, and hemorrhagic complications occur during ECMO support, but the investigators are limited in the monitoring and diagnosis of ABI while on ECMO as currently available imaging modalities (i.e. ultrasound [US], computed tomography [CT]) have low sensitivity for early hypoxic, cerebrovascular, and ischemic brain injuries. The sensitivity of these modalities increases only when it is too late to effectively intervene. Standard magnetic resonance imaging (MRI) is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ECMO devices. Swoop (Hyperfine, Guilford, CT) is an FDA cleared ultralow-field portable MRI system that can be used at the bedside and has been studied in critically ill adults with various types of ABI. This novel bedside MRI has been safely operated in clinical environments with equipment that is typically not MRI compatible. A few adult and pediatric ECMO patients have undergone bedside brain MRIs showing feasibility. Yet, what remains unknown is the true prevalence and timing of hypoxic, cerebrovascular, and ischemic brain injuries in pediatric ECMO.

Enrollment

30 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participants that will be or are admitted to the Pediatric Intensive Care Unit, Cardiac Intensive Care Unit, or the Neonatal Intensive Care Unit
Ages 0-17 years
Participants that are at high risk for undergoing ECMO or are currently undergoing venovenous or venoarterial ECMO

• High risk participants include, but are not limited to:
Undergoing cardiac surgery
Congenital heart disease
Congenital diaphragmatic hernia
Refractory hypoxemic and/or hypercarbic respiratory failure
Vasoactive-refractory shock

Exclusion Criteria

Pregnancy
Active implants such as:
- Pacemaker
- Implanted defibrillator
- Implanted insulin pump
- Deep brain stimulator
- Vagus nerve stimulator
- Cochlear implant
- Programmable shunt
MRI incompatible surgical hardware (e.g., staples, screws, etc.)
Metal-containing tattoos or permanent make-up on head or neck
Suspected metal in eye, e.g.,
Former or current welders, metal workers, or individuals with a metal injury
Metal shrapnel
Passive implants are considered MRI-conditional